Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148

March 1, 2023 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Phase 3, Multicenter, Open Label Trial to Evaluate the Long-term Safety and Tolerability of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder

The purpose of this study is to evaluate the long-term safety and tolerability of brexpiprazole in children and adolescent patients, aged 5 to 17, with irritability associated with autism spectrum disorder.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • For additional information regarding sites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 5 to 17 year of age or turned 18 while enrolled in the 331-201-00148 study
  • Autism Spectrum Disorder
  • Completion of 331-201-00148 trial
  • Investigator assessment

Exclusion Criteria:

  • Did not complete treatment period or incurred significant protocol deviations during 331-201-00148 study
  • Sexually active males or female of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose
  • Female with positive pregnancy test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Brexpiprazole
Drug: Brexpiprazole
Oral tablet; taken once daily
Other Names:
  • OPC-34712
  • LuAF41156

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Baseline to Week 26
Adverse Events occurring from baseline to Week 26
Baseline to Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aberrant Behavior Checklist (ABC-I)
Time Frame: Baseline to Week 26
Aberrant Behavior Checklist- Irritability subscale score (ABC-I)
Baseline to Week 26
Clinical Global Impression (CGI-S)
Time Frame: Baseline to Week 26
Clinical Global Impression - Severity (CGI-S)
Baseline to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

H. Lundbeck A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2020

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

February 4, 2020

First Submitted That Met QC Criteria

February 4, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 331-201-00191

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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